Nutraceutical-based therapy in the management of disorders of the jaw joint and muscles that control jaw movement
| ISRCTN | ISRCTN71924789 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71924789 |
- Submission date
- 31/10/2023
- Registration date
- 08/12/2023
- Last edited
- 08/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Temporomandibular disorders (TMDs) are a subgroup of craniofacial pain disorders, involving pain and dysfunction of the temporomandibular joint (TMJ), masticatory muscles and associated musculoskeletal structures of the head and neck. This study aims to evaluate the effects of short-term treatments with nutraceuticals in subjects with TMDs focusing on the improvement of quality of life in terms of the reduction of painful TMD symptoms, sleep and psychological outcomes.
Who can participate?
Patients with TMDs aged between 18 and 75 years old
What does the study involve?
The nutraceutical used is composed of Boswellia Serrata Casperome, Magnesium, Tryptophan and vitamins B2 and D with a posology of 1 tablet per day before sleep for 40 days.
Subjects with neuromuscular disorders in the temporomandibular region are eligible for the study and randomly divided into 2 groups (treatment group and control group). The presence of muscle pain, headache, neck pain and sleep/emotional disorders will be assessed at T0 (baseline) and at T1 (after treatment/40 days). The treatments with nutraceuticals and their respective controls will be compared with respect to painful symptomatology. Further tests will be performed to assess differences in sleep/emotional disorders between groups.
What are the possible benefits and risks of participating?
A reduction in muscle tension is expected, which also has a beneficial effect on sleep quality. No adverse effects are expected. The possibility of no effect may be contemplated.
Where is the study run from?
Department of Oral and Maxillo-facial Sciences, Sapienza University of Rome (Italy)
When is the study starting and how long is it expected to run for?
February 2018 to 20 June 2023
Who is funding the study?
Sapienza University of Rome (Italy)
Who is the main contact?
Paola di Giacomo, p.digiacomo@uniroma1.it (Italy)
Contact information
Public, Scientific, Principal Investigator
Via Caserta 6
Rome
00161
Italy
 ORCID ID |
0000-0002-5657-1684 |
|---|---|
| Phone | None provided |
| p.digiacomo@uniroma1.it |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Nutraceutical-based therapy in the management of temporomandibular disorders |
| Study acronym | NTTMD |
| Study objectives | Can a broad-spectrum nutraceutical treatment be considered as effective as short-term therapy for temporomandibular disorders (TMDs)? |
| Ethics approval(s) |
Approved 24/05/2018, Department of Oral and Maxillo-facial Sciences, Sapienza university of Rome (Via Caserta 6, Rome, 00161, Italy; +39 0649976611; dip.odonto@cert.uniroma1.it), ref: 0000698 |
| Health condition(s) or problem(s) studied | Temporomandibular joint disorders |
| Intervention | This study investigates whether a broad-spectrum nutraceutical treatment is as effective as short-term therapy for temporomandibular disorders (TMDs). Computer-generated randomization will be undertaken with a random allocation sequence and a block size of 2. Specifically, in the case that no orthopedic treatment has yet started, patients will be enrolled in: Treatment with Nutraceutical (Nutraceutical group – Group I); No treatment (Control Group Ia). In case of ongoing occlusal splint therapy, patients will be enrolled in: Treatment with Neutraceutical and splint therapy (Neutraceutical + Splint Group – Group II); Treatment with occlusal splint only (Control Group IIa). The participants are blinded to group assignments. Participants will be told that they have an equal chance of being assigned to one of the two arms. After the recruitment phase, subjects assigned to Groups I and II will take one tablet of the supplement per day before sleep for 40 days. The administered nutraceutical was based on Magnesium, Tryptophane, Boswellia Serrata Casperome®, and Vitamins B2, D, and PP. |
| Intervention type | Supplement |
| Primary outcome measure | Intensity of temporomandibular disorder pain measured using the Verbal Numerical Scale (VNS) at T0 ( before treatment) and T1 (after treatment) |
| Secondary outcome measures | 1. Improvement of quality of life relating to physical disabilities measured using the Verbal-Numerical Scale (VNS) to report the severity, if present, of comorbidities, such as headache and neck pain and presence/absence of sleep/emotional disturbances (only with a dichotomic classification yes/no) at T0 and T1 2. Analysis of mandibular function (presence of articular noises, evaluation of functional excursions and maximum mouth opening) and palpatory examination were also recorded at T0 and T1 |
| Overall study start date | 20/02/2018 |
| Completion date | 20/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 193 |
| Key inclusion criteria | 1. Presence of dysfunctions of the craniocervical musculature, in the presence or absence of parafunction 2. Presence of muscular pain at the level of the masseter of the medium-high entity with a minimum value of 40 and a maximum of 100 according to the VNS (verbal numerical scale), spontaneous and/or investigated by palpatory manoeuvres 3. Presence of arthralgia in at least one temporomandibular joint 4. Presence of the following comorbidities such as headache attributed to temporomandibular disorders, cervicalgia 5. Presence of sleep disturbances (no OSAS) and emotional factors (stress and anxiety) investigated with a nominal scale (presence or absence) 6. Patients waiting for or undergoing conservative gnathological therapy |
| Key exclusion criteria | 1. Psychiatric pathologies 2. Systemic pathologies with disease-related muscular impairment 3. Pain therapy or myorelaxant medication |
| Date of first enrolment | 01/01/2021 |
| Date of final enrolment | 01/01/2022 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via Caserta 6
Rome
00161
Italy
Sponsor information
University/education
Via Caserta 6
Rome
00161
Italy
| Phone | +39 (0)649976611 |
|---|---|
| dip.odonto@cert.uniroma1.it | |
| Website | https://www.uniroma1.it/it/ |
"ROR" |
https://ror.org/02be6w209 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Sapienza University of Rome, Università degli Studi di Roma "La Sapienza”, Sapienza-Università di Roma, Sapienza, Uniroma1
- Location
- Italy
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact and peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Paola di Giacomo, p.digiacomo@uniroma1.it. All consent will be requested and obtained from each participant before participating in the study. Anonymous (without any sensible data) database with each collected data will be available for 5 years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/07/2024 | 08/07/2024 | Yes | No |
Editorial Notes
08/07/2024: Publication reference added.
14/11/2023: Study's existence confirmed by the Department of Oral and Maxillo-facial Sciences, Sapienza university of Rome (Italy).
